BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMAGER II UROLOGY TORQUEABLE CATHETER

    MDR report key: 16333538 · Received February 9, 2023

    Report

    Report Number
    3005099803-2023-00610
    Event Type
    Injury
    Date Received
    February 9, 2023
    Date of Event
    August 1, 2020
    Report Date
    April 17, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOD
    PMA / PMN Number
    K102527
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: DATE OF EVENT: THE EXACT DATE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN AUGUST 2020. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE SUSPECTED LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H2: ADDITIONAL INFORMATION: B5 (DESCRIBE EVENT OR PROBLEM), AND BLOCK H6 (PATIENT CODES) BLOCK H6: IMDRF PATIENT CODES E233605 CAPTURE THE REPORTABLE EVENT OF SEPTIC SHOCK. IMDRF IMPACT CODES F0801 AND F2301 CAPTURE THE REPORTABLE EVENT OF ICU ADMISSION AND CYSTOSCOPY STENT PLACEMENT.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: THE EXACT DATE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 2020. THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE SUSPECTED LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. IMDRF PATIENT CODES E233605 AND E2328 CAPTURE THE REPORTABLE EVENT OF SEPTIC SHOCK AND URETERAL OBSTRUCTION. IMDRF IMPACT CODES F0801 AND F2301 CAPTURE THE REPORTABLE EVENT OF ICU ADMISSION AND CYSTOSCOPY STENT PLACEMENT.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON, 8/10 DILATOR, PERCUTANEOUS ACCESS NEEDLE AND SHEATH IMAGER II SET WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2020. THE PATIENT EXPERIENCED SEPTIC SHOCK, REQUIRING ADMISSION TO INTENSIVE CARE UNIT (ICU) AND CYSTOSCOPY STENT PLACEMENT.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON, 8/10 DILATOR SHEATH SET, PERCUTANEOUS ACCESS NEEDLE AND IMAGER II WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2020. THE PATIENT EXPERIENCED URETERAL OBSTRUCTION AND SEPTIC SHOCK, REQUIRING ADMISSION TO INTENSIVE CARE UNIT (ICU) AND CYSTOSCOPY STENT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358481 IMAGER II UROLOGY TORQUEABLE CATHETER CATHETER, UROLOGICAL KOD BOSTON SCIENTIFIC CORPORATION M0064003001

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention| H